N/A N=100 Randomized Double-blind Other

Heated Humidification System Breathing Circuit for Maintenance of Body Temperature in Pediatric Patients

Temperature Change, Body

Bottom Line

View on ClinicalTrials.gov: NCT03896867 ↗

Enrolled (actual)

100

Serious AEs

37.0%

Results posted

Mar 2025

Primary outcome: Primary: Rectal Temperature — 36.7; 37.2 degrees celsius

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Anapod™ Humi-Therm Heated Humidification System Breathing Circuit (Device); Bair Hugger™ Warming Blanket (Device)
Age: Pediatric, Adult
Sex: All
Sponsor: University of Minnesota
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Rectal Temperature	36.7; 37.2	—
SECONDARY Need for Hyperthermic or Hypothermic Rescue	11; 22	—

Summary

Our goal is to evaluate the efficacy of the Westmed system vs the Bair Hugger Blanket.

Eligibility Criteria

Inclusion Criteria

Pediatric patients undergoing elective, scheduled dental procedures at Masonic Children's hospital requiring general anesthesia with endotracheal intubation, anticipated to last 1-6 hours or longer

Exclusion Criteria

Parent refusal of consent
Patient refusal of assent (if applicable)
Additional procedures (combined procedures) that involve other specialties besides dentists and other parts of the patient's body other than the oral cavity.
History of diseases associated with temperature dysregulation (active hyperthyroidism, dysautonomia, osteogenesis imperfecta, history of malignant hyperthermia)
Patients that will not be intubated for the procedure

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03896867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.